the suitability of two skin care regimens in moderate to severe facial rosacea

Conditions: Rosacea

Summary: this study evaluates a nature-based sensitive skin regimen (nbssr), as a suitable adjunct topical application to prescription medication when administered daily over the course of four weeks, in moderate to severe rosacea in comparison to the control regimen (cr).


Eligibility criteria:
inclusion criteria: * subjects must be female 25-60 years of age with moderate facial rosacea at screening and 6 or 7 papules and/or pustules; as well as, no other known medical conditions that, in the investigator's opinion, may interfere with study participation. * women of childbearing potential must be willing to use a form of birth control during the study. for the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, norplant(r), depo-provera(r) double barrier methods (e.g., condom and spermacide) and abstinence. * subjects must provide written informed consent. * willingness to comply with the study design and procedures. * subjects who agree to sign a photography release form. exclusion criteria: * any dermatological disorder, except rosacea requiring the use of prescription medication, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, * subjects who are using any anti-aging skin care products within 4 weeks of study enrollment. * subjects who are not willing to use only the assigned study products and nothing else, except for self-selected colored cosmetics that must remain unchanged during the study, to their face. * subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products. * subjects, who are pregnant, breast feeding, or planning a pregnancy. * subjects with clinically significant unstable medical disorders. * subjects who are unwilling or unable to comply with the requirements of the protocol. * subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. * subjects who have participated in any clinical study in the past 30 days or are currently participating in any other clinical study. * subjects with any planned surgeries and/or invasive medical procedures during the course of the study. * subjects who started hormone replacement therapies (hrt) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of hrt or hormones for birth control during the study. * subjects who currently or frequently use high doses of anti-inflammatory drugs for a defined medication condition. aspirin use should not exceed 2 tablets (650 mg) per day. * subjects currently receiving any anticancer, immunosuppressive treatments/ medications (e.g., azathioprine, belimumab, cyclophosphamide, enbrel, imuran, humira, mycophenolate mofetil, methotrexate, prednisone, remicade, stelara.), or radiation as determined by the initial paperwork. * subjects with a history of immunosuppression/immune deficiency disorders (including (hiv infection or aids) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, enbrel, imuran, humira, mycophenolate mofetil, methotrexate, prednisone, remicade, stelara.) and/or radiation as determined by study documentation.